Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ERYTHROMYCIN ETHYLSUCCINATE
ROYCE PHARMA MANUFACTURING SDN. BHD.
ERYTHROMYCIN ETHYLSUCCINATE
500 Tablet Tablets; 100Tablet Tablets; 1000Tablet Tablets; 10Tablet Tablets
ROYCE PHARMA MANUFACTURING SDN. BHD.
1 RA Department From: Farmakovigilans (Unit Risk Communication (RiMUP))Sent: Thursday, 6 December, 2018 11:32 AM To: reg@royce-pharma.com Subject: Erymin -400 Tablet Rimups Attachments: RiMUP-ErymT400 (ENG) 240918.pdf; RiMUP-ErymT400 (BM) 240918.pdf Dear Ms Huda, I have rejected the ERYMIN-400 TABLET RIMUPS today as the approved PI was not updated with the directive issued on 12 Dec 2017. Please refer to Directive Bil. (33) dlm. BPFK/PPP/07/25 Jld 1 in NPRA website. This is a TOTAL REJECTION for ERYMIN-400 TABLET RIMUPS RiMUP as you need to proceed with variation submission to update the PI and relevant section A as soon as possible. The evaluation will only resume after they are updated accordingly. For the following submission for this product after the variation is approved, please submit the clean copy of RiMUPs with cover letter hardcopy manually to us. Do contact me if you have any further queries. Thank you. Regards, Bavahrni PHARMACOVIGILANCE SECTION | CENTRE FOR POST REGISTRATION AND COSMETIC CONTROL | NATIONAL PHARMACEUTICAL REGULATORY DIVISION (NPRA) MINISTRY OF HEALTH MALAYSIA. LOT. 36, JALAN UNIVERSITI, 46200 PETALING JAYA, SELANGOR, MALAYSIA. TEL : 03-78835499 | FAX : 03-79567151 Belgenin tamamını okuyun
7 8 9 10 Revision date: 071019 Appropriate monitoring should be undertaken and dosage should be a d j u s t e d a s n e c e s s a r y . C a u t i o n w h e n t a k e n w i t h t e r f e n a d i n e or a s t e m i z o l e b e c a u s e i t i s l i k e l y t o r e s u l t i n a n e n h a n c e d r i s k of c a r d i o t o x i c i t y . T h e m e t a b o l i s m o f t e r f e n a d i n e a n d a s t e m i z o l e is s i g n i f i c a n t l y a l t e r e d w h e n e i t h e r i s t a k e n c o n c o m i t a n t l y with erythromycin. Rare cases of serious cardiovascular events have been observed, including Torsades de pointes, other ventricular arrhythmias and c a r d i a c a r r e s t . D e a t h h a s b e e n r e p o r t e d w i t h t h e terfenadine/ erythromycin combination. Elevated cisapride levels have been reported in patients receiving erythromycin and cisapride concomitantly. This may result in QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsades de pointes. Similar effects have been observed with concomitant administration of pimozide and clarithromycin, another macrolide antibiotic. PREGNANCY AND LACTATION: The safety of erythromycin for use during pregnancy has not been e s t a b l i s h e d . E r y t h r o m y c i n c r o s s e s t h e p l a c e n t a l barrier. Erythromycin also appears in breast milk. SIDE EFFECTS: Skin and Subcutaneous Disorders F r e q u e n c y n o t k n o w n : s e v e r e c u t a n e o u s a d v e r s e reactions ( S C A R s i n c l u d i n g S t e v e n s - J o h n s o n s y n d r o m e ( S J S , toxic e p i d e r m a l n e c r o l y s i s ( T E N, d r u g r e a c t i o n w i t h e o s i n o p h i l i a and systemic symptoms (DRESS & acute generalised exanthematous pustulosis (AGEP. The most frequent adverse effects of erythromycin preparations are gastrointestinal, e.g. abdominal cramping and discomfort, and are d o s e - r e l a t e d . N a u s e a , v o m i t i n g a n d d i a r r h o e a o c c u r infrequently with Belgenin tamamını okuyun